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Background We hypothesized that in patients with hepatitis C virus (HCV) genotype 2 or 3 in whom HCV RNA is not detectable after 4 weeks of therapy, 12 weeks of treatment is as effective as 24 weeks.
Methods A total of 283 patients were randomly assigned to a standard 24-week regimen of peginterferon alfa-2b at a dose of 1.0 µg per kilogram weekly plus ribavirin at a dose of 1000 mg or 1200 mg daily, on the basis of body weight. Of these, 70 patients were assigned to the 24-week regimen (standard-duration group) and 213 patients to a variable regimen (variable-duration group) of 12 or 24 weeks, depending on whether tests for HCV RNA were negative or positive at week 4. The primary end point was HCV that was not detectable by polymerase-chain-reaction (PCR) assay 24 weeks after the completion of therapy.
Results In the standard-duration group, 45 (64 percent) patients had HCV that was not detectable by PCR assay at week 4, as compared with 133 (62 percent) in the variable-duration group (difference [the rate in the standard-duration group minus that in the variable-duration group], 2 percent; 95 percent confidence interval, –11 to 15 percent). Fifty-three patients (76 percent) in the standard-duration group and 164 patients (77 percent) in the variable-duration group had a sustained virologic response (difference, –1 percent; 95 percent confidence interval, –13 to 10 percent). Fewer patients in the variable-duration group receiving the 12-week regimen had adverse events and withdrew than in the group receiving the 24-week regimen (P=0.045). The rate of relapse (defined as HCV not detectable at the end of treatment but detectable at the end of follow-up) was 3.6 percent in the standard-duration group and 8.9 percent in the variable-duration group (P=0.16). Overall, the rate of sustained virologic response was 80 percent among patients with HCV genotype 2 and 66 percent among those with genotype 3 (P<0.001).
Conclusions A shorter course of therapy over 12 weeks with peginterferon alfa-2b and ribavirin is as effective as a 24-week course for patients with HCV genotype 2 or 3 who have a response to treatment at 4 weeks.
Source Information
From the Gastroenterology Unit, IRCCS Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo (A.M., R.S., F. Spirito, A.A.); the Department of Internal Medicine, Hospital Canosa, Canosa (N.M.); the Department of Internal Medicine, University La Sapienza, Rome (G.L.R.); the Department of Internal Medicine, Hospital Venosa, Venosa (V.C.); the Department of Internal Medicine, Federico II University, Naples (M.P.); the Department of Gastroenterology, Ospedali Riuniti, Foggia (F.V.); the Department of Infectious Disease, University of Foggia, Foggia (G.S.); the Department of Internal Medicine, Hospital Casarano, Casarano (D.B.); the Department of Internal Medicine, Hospital Policoro, Policoro (M.A.); the Department of Internal Medicine, Sant'Andrea Hospital, Rome (M.R.); the Liver Unit, Sovrano Ordine di Malta, Rome (F.Z.); and the Department of Internal Medicine, Santissima Annunziata Hospital, Taranto (F. Sogari) — all in Italy.
Address reprint requests to Dr. Mangia at the Gastroenterology Unit, Casa Sollievo della Sofferenza Hospital IRCCS, 71013 San Giovanni Rotondo, Italy, or at a.mangia{at}tin.it.
Related Letters:
Peginterferon Alfa-2b and Ribavirin for 12 versus 24 Weeks in HCV Infection
Borg B. B., Hoofnagle J. H., Henry M. J., Mangia A., Andriulli A.
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N Engl J Med 2005;
353:1182-1183, Sep 15, 2005.
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